Her-2

[TryToKeepUp]

So i recently finished reading a book called Her-2 which is about the amazing story of a cancer research doctor named Denny Slamon. Has anyone else read this? What are your thoughts?

[jobob]

I read it a long time ago. It's a very interesting account of what goes into drug development, and gives one an idea of the time and costs involved - and, in this case, the politics - in bringing a new drug to market.

I used to work with another person mentioned in the book, John Curd (after he left Genentech).

[wolfak]

There's a book on this story? I've read most of the publications related to his work on Her2/neu and Herceptin for my Cancer Targets class last spring. It's very nice science; I think it would be interesting to read it in layperson language. Thanks!

[gingerale]

Lifetime is about to premiere a movie called "Living Proof" or something like that. Is that what this movie is about??

[jobob]

Hot dang, so it is! Good catch.

http://en.wikipedia.org/wiki/Living_Proof_(film)

[gingerale]

That's great! I was wanting to watch it but not really sure what it was even about. I'll definitely have to catch it now.

[TryToKeepUp]

Oh they are? That's pretty awesome!

I started reading the book after my cousin was diagnosed with cancer... i wanted to learn more about the types of drugs were being used on patients and how much it costs for the reproduction of a new drug and if they're even effective.

[jobob]

All of the drugs approved by the FDA are effective for the particular disease (aka "indication") that drug is approved for. That's what clinical trials are all about - first the drug has to be shown to be safe, then it has to be shown to be effective in treating the particular disease.

The trouble with cancer is that there are so many different types, and treatment for one type of cancer might not work for another type of cancer. Take breast cancer, for instance. Some breast cancers respond very well to Herceptin, which is an antibody against Her-2. But some breast cancers don't involve Her-2 and thus Herceptin isn't effective.

As for the costs involved, clinical trials cost a freaking fortune - millions and millions of dollars, depending on the disease being treated. And those costs are generally borne by the company developing the drug. Huge pharma companies can absorb the costs of clinical trials, but for smaller companies its a make-or-break proposition. For the smaller companies, they usually try to partner with a larger company to help absorb the cost of development (and share in any profits if its a winner).

Thing is, in order to partner a drug, often the small company has to take the drug through at least the early stages of clinical trials before they can get a larger company interested in partnering. So if a drug fails in the early stage of a trial, in many instances that's enough to kill a small company, even if that company might have other promising drugs in its pipeline. That's why if you follow biotech news, every month you see headlines along the lines of "such and such-drug fails to meet endpoint, company x lays of 80% of its workforce". It's a huge gamble for a company to try to take a drug to market.

And that's a sad fact about the economics of drug development. Many companies (at least smaller companies) cannot risk the uncertainty of developing drugs for diseases in which the clinical trials are extremely costly - say, if they require very long study times and/or very large numbers of patients. Take MS for instance - the trials for MS drugs are extremely lengthy and involve hundreds of patients in Phase III so companies without deep pockets are hesitant to develop MS drugs. Broadly speaking, cancer is somewhat "easier" to test, so more companies tend to go after cancer drugs.

Diseases that are difficult to treat, have very 'fuzzy' endpoints, or are not that widespread (smaller patient population -> smaller return on investment) tend to get the short shrift in drug development.

I'm of course generalizing out the wazoo here but hopefully that gives you the drift.

[gnat23]

I work at Genentech now! The amount of effort that goes into each release is phenomenal to me.

-- gnat!

[Smurfette]

jobob! thanks for the mini lesson... i had no clue.. but it's interesting to see how people opt out for testing cancer drugs since its cheaper.. i wish there could be one drug- that has one universal purpose- just to cure, with absolutely no side effects or anything

[jobob]

Isn't that what martinis are for ?

Oh, you said no side effects. Nevermind.

[Tweet]

haha true. I guess it's cool that they made a movie from the book..

[Smurfette]

Yeah very curious to see the movie. Its actually airing tomorrow
night on the Lifetime channel. It's called Living Proof...her is all the
information: http://www.mylifetime.com/on-tv/movies/living-proof
Hope its good!

[jobob]

Harry Connick Jr, what's not to like?

I'll be firing up the DVR. I do hope they get the facts right, it drives me nutz when the facts are messed up for the sake of the story.

[jobob]

Regarding my previous post about the economics of drug development, I just came across this ...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Cell Genesys, Inc. (Nasdaq:CEGE - News) today announced its decision to terminate the VITAL-1 Phase 3 clinical trial of GVAX immunotherapy in patients with asymptomatic metastatic hormone-refractory prostate cancer. The trial was fully enrolled in 2007 with 626 patients and compared GVAX immunotherapy to Taxotere® (docetaxel) chemotherapy plus prednisone. The Company terminated the trial based on the results of a previously unplanned futility analysis conducted by the study’s Independent Data Monitoring Committee (IDMC) which indicated that the trial had less than a 30 percent chance of meeting its predefined primary endpoint of an improvement in survival.

... As a result of these circumstances, Cell Genesys will reduce its staff of 290 by approximately 75 percent by year-end with further reductions anticipated in the first half of 2009 as additional activities are phased out.

Such is the world of drug development.